A Trial of "Coping Coach," a Web-based Preventive Intervention for Children

Not Applicable

Completed

Conditions: Stress Disorders, Post Traumatic

Interventions: Behavioral: Coping Coach

Registration Number: NCT01653288

Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary: This study will evaluate the impact of a psychosocial intervention, Coping Coach, delivered online to children who have experience an acute medical event.

The core study hypotheses are that children receiving the intervention will (1) endorse fewer maladaptive trauma-related appraisals and (2) demonstrate more adaptive coping (more support-seeking, more cognitive restructuring, less avoidant coping) at a 6-week follow-up, and (3) demonstrate lower severity of post traumatic stress (PTS) symptoms and higher health related quality of life (HRQOL) at 12 week follow-up.

Detailed Description: The purpose of this study is to evaluate the feasibility and provide an initial evaluation of the efficacy of Coping Coach, a new web-based intervention for children experiencing acute medical events.

The study aims to (1) assess and maximize intervention feasibility, (2) conduct an initial efficacy testing (pilot RCT) for proximal outcomes (appraisals, coping) and subsequent child health outcomes (PTS reactions, HRQOL), and (3) refine the conceptual framework and optimize the intervention effectiveness.

Study Design:

This study will progress in multiple stages:

Pilot study: 20 children experiencing a potentially traumatic medical event will be given the Coping Coach intervention with follow-up at 6 weeks. This pilot will examine initial feasibility, usability, acceptability, and child engagement/ comprehension of the intervention.

Additional Pilot Study (2015): 20 children treated in the ED or admitted to the hospital with injury due to non-family violence will be provided with the Coping Coach intervention. Other inclusion and exclusion criteria, as well as baseline, 6- and 12-week assessments parallel those from the RCT stage described below. This pilot will examine feasibility, engagement, and estimate pre-post changes in key measures in children with violence exposure.

RCT: A wait-list design will compare intervention use with a waitlist control on proximal and child health outcomes at 6, 12, and 18 weeks after baseline enrollment. The Coping Coach intervention will be provided to the waitlist control after the 12 week assessment. 70 children will be enrolled, 35 in each arm. (Assessment of feasibility and engagement will continue in this stage.)

The rest of this CLINICALTRIALS.GOV record describes the RCT (N=72).

The Pilot and RCT combined will help us prepare for rigorous large-scale RCT of Coping Coach.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

Inclusion Criteria

Subject is 8 to 12 years of age
Child has experienced a potentially traumatic medical event* within the past 2 weeks
Child's GCS > 12
Child speaks English well enough to complete the measures and participate in an interview
Child has access to the Internet and telephone
Parental/legal guardian informed consent and child assent

Exclusion Criteria

Child's current medical condition or cognitive limitations preclude participating in an interview
Child's acute medical event is due to family violence or suspected child abuse
Child or parent has been arrested or is subject to legal proceedings related to the index incident
In the index event, child or parent was a perpetrator of violence (or participant in mutual violence)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coping Coach Waitlist Control	Coping Coach	Treatment as usual from baseline to 12 week follow-up assessment. Then receive access to Coping Coach intervention after 12 week follow-up for use (self-guided, with email reminders) over the next 6 weeks.
Coping Coach	Coping Coach	Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.

Primary Outcome Measures

Name	Time	Method
Mean Time Spent Using the Intervention	6 weeks	Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here.
Feasibility of the Coping Coach Online Intervention	6 weeks	Feasibility was measured using automated monitoring data, the number of participants who logged in at least once and the number of participants who completed the entire online intervention are presented here.

Secondary Outcome Measures

Name	Time	Method
a Preliminary Assessment of the Efficacy of the Intervention	12 weeks	Child PTSD Symptom Scale (CPSS) measures child posttraumatic stress symptoms, possible range 0-51, high scores = more severe. Pediatric Quality of Life Inventory (PedsQL) measures child health-related quality of life, possible range 0-100, high scores = better quality of life. How I Coped Under Pressure Scale (HICUPS) measures child avoidance coping strategies, possible range 12-48, high scores = more use of avoidance coping. Child Posttraumatic Cognitions Inventory (CPTCI) measures child post trauma cognitive appraisals, possible range 25-100, high scores = more maladaptive appraisals.